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Intrapleural Dornase and Tissue Plasminogen Activator in pediatric empyema (DTPA): a study protocol for a randomized
Michael H Livingston1, Sanjay Mahant2, Felix Ratjen2
1McMaster Children's Hospital, McMaster University, 1280 Main Street West, Hamilton, ON, L8S 4K1, Canada.
Insights
This study investigates if adding dornase alfa to fibrinolytics improves outcomes for pediatric empyema. The trial will compare this combined treatment to fibrinolytics alone in children requiring chest tubes.
Area of Science:
- Pediatric Pulmonology
- Thoracic Surgery
- Infectious Diseases
Background:
- Intrapleural dornase alfa and fibrinolytics reduced hospital stay in adults with empyema.
- The efficacy and safety of this combined treatment in pediatric empyema are unknown.
Purpose of the Study:
- To assess the safety, effectiveness, and cost-effectiveness of intrapleural dornase alfa plus fibrinolytics versus fibrinolytics alone in children with empyema.
- To determine if this combination therapy can reduce length of hospital stay and improve other clinical outcomes in pediatric patients.
Main Methods:
- A multicenter, placebo-controlled, parallel-design randomized controlled trial.
- Children with empyema requiring chest tube insertion will receive either tissue plasminogen activator (tPA) with dornase alfa or tPA with normal saline for 3 days.
- Blinding will be maintained for participants, caregivers, clinicians, and researchers.
Main Results:
- Primary outcome: length of hospital stay from chest tube insertion to discharge.
- Secondary outcomes: time to discharge criteria, chest tube duration, fever duration, need for additional procedures, adverse events, readmission, cost, and mortality.
Conclusions:
- This trial aims to provide crucial data on a novel treatment strategy for pediatric empyema.
- Findings will inform clinical practice regarding the use of dornase alfa in conjunction with fibrinolytics for children with this condition.
Background:
A randomized controlled trial of adults with empyema recently demonstrated decreased length of stay in hospital in patients treated with intrapleurally administered dornase alfa and fibrinolytics compared to fibrinolytics alone. Whether this treatment strategy is safe and effective in children remains unknown.
Methods/Design:
This study protocol is for a superiority, placebo-controlled, parallel-design, multicenter randomized controlled trial. The participants are previously well children admitted to a children's hospital with a diagnosis of empyema requiring chest tube insertion and fibrinolytics administered intrapleurally. Children will be randomized after the treating physician has decided that pleural drainage is required but prior to chest tube insertion. After chest tube insertion, participants in the treatment group will receive intrapleurally administered tissue plasminogen activator (tPA) 4 mg followed by dornase alfa 5 mg. Participants in the placebo group will receive tPA 4 mg followed by normal saline. Study treatments will be administered once daily for 3 days. All participants, parents or caregivers, clinicians, and research personnel will remain blinded. The primary outcome is length of stay from chest tube insertion to discharge from hospital. Secondary outcomes include time to meeting discharge criteria, chest tube duration, fever duration, need for additional procedures, adverse events, hospital readmission, cost of hospitalization, and mortality.
Discussion:
This multicenter randomized controlled trial will assess the safety, effectiveness, and cost-effectiveness of combined treatment with dornase alfa and fibrinolytics compared to fibrinolytics alone for the treatment of empyema in children.
Trial Registration:
ClinicalTrials.gov: NCT01717742 . Registered on 8 October 2012.
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